Adverse Event (AE)

Any untoward medical occurrence in a clinical trial participant or patient receiving a pharmaceutical product, regardless of whether it has a causal relationship with the treatment. Adverse events encompass all unfavorable signs, symptoms, laboratory abnormalities, and diseases that emerge or worsen during the study period. AE reporting and coding (using MedDRA) are mandatory regulatory requirements for all clinical trials.

示例

• Headache reported during an antihypertensive trial (may or may not be drug-related)
• Elevated liver transaminases detected on routine lab monitoring during statin therapy
• Falls in elderly patients during a sedative hypnotic trial